Lordiphens

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LORDEFENCE

Composition:

Active substance: benzidamine hydrochloride;

1 ml of oral spray contains 1.5 mg of benzidamine hydrochloride;

Excipients: saccharin, sodium hydrogencarbonate, polysorbate 20, mint flavouring, methylparahydroxybenzoate (E 218), glycerol, ethanol 96%, purified water.

Pharmaceutical form. Oral spray.

Basic physicochemical properties: clear, colourless liquid with a characteristic smell and taste of mint.

Pharmacotherapeutic group. Agents for use in dentistry. Other agents for local application in the oral cavity. ATC code A01A D02.

Pharmacological Properties

Pharmacodynamics

Benzydamine is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and anti-exudative properties.

Clinical studies have demonstrated that benzydamine is effective in relieving symptoms associated with localized irritative pathological conditions in the oral cavity and pharynx. In addition, benzydamine exerts anti-inflammatory and local analgesic action, producing a local anesthetic effect on the mucous membrane of the oral cavity.

Pharmacokinetics

Absorption through the mucous membranes of the oral cavity and pharynx has been confirmed by the presence of measurable amounts of benzydamine in human plasma. However, this is insufficient to produce any systemic pharmacological effect. Excretion occurs primarily via the urine, mainly as inactive metabolites or conjugated compounds.

It has been shown that topical application leads to accumulation of an effective concentration of benzydamine in inflamed tissues due to its ability to penetrate through the mucous membrane.

Clinical Characteristics

Indications

Symptomatic treatment of irritations and inflammations of the oropharynx; pain caused by gingivitis, stomatitis, pharyngitis; in dentistry after tooth extraction or for prophylactic purposes.

Contraindications

Hypersensitivity to the active substance or to other components of the medicinal product.

Interaction with other medicinal products and other forms of interaction

Interaction studies have not been conducted.

Special precautions for use

If sensitivity occurs during prolonged use, treatment should be discontinued and medical advice should be sought so that appropriate therapy can be prescribed.

In some patients, oral/pharyngeal mucosal ulcers may be caused by serious underlying pathological conditions. Therefore, patients whose symptoms worsen or do not improve within 3 days, or who develop fever or other new symptoms, should consult a physician or dentist, as appropriate.

Benzidamine should not be used in patients with hypersensitivity to acetylsalicylic acid or to other nonsteroidal anti-inflammatory drugs.

This medicinal product may cause bronchospasm in patients with bronchial asthma or a history of bronchial asthma. Such patients must be warned accordingly.

This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

For athletes: the use of medicinal products containing ethanol may result in a positive anti-doping test, depending on the thresholds established by certain sports federations.

This medicinal product contains methylparahydroxybenzoate (methylparaben), which may cause allergic reactions (possibly delayed), and in rare cases, bronchospasm.

Use during pregnancy or breastfeeding

There are currently insufficient data available on the use of benzidamine in pregnant or breastfeeding women. It has not been established whether this medicinal product passes into breast milk. Animal studies are insufficient to allow conclusions regarding the effects of this medicinal product during pregnancy or breastfeeding. The potential risk to humans is unknown.

Lodifen should not be used during pregnancy or breastfeeding.

Ability to affect the speed of reactions when driving or operating machinery

When used at the recommended doses, this medicinal product does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

Before use, the spray device must be primed.

Pressing the spray device produces a spray containing 1 dose – 0.17 mL, corresponding to 0.255 mg of benzidamine hydrochloride.

Dosage

Adults: 4–8 sprays 2–6 times daily.

Children (6–12 years): 4 sprays 2–6 times daily.

Children (4–6 years): 1 spray per 4 kg body weight, up to a maximum dose equivalent to 4 sprays, 2–6 times daily.

Do not exceed the recommended dosages.

Children

This medicinal product can be used in children aged 4 years and older.

Overdose

There have been no reports of overdose with benzidamine when used topically.

In case of accidental ingestion of a large amount of benzidamine (> 300 mg), especially in children, poisoning may occur. Characteristic signs of overdose following oral administration include gastrointestinal symptoms (most commonly nausea, vomiting, abdominal pain, esophageal irritation) and central nervous system symptoms (possible dizziness, hallucinations, excitement, convulsions, tremor, increased sweating, ataxia, anxiety, and irritability).

Such acute overdose requires immediate gastric lavage, correction of fluid and electrolyte imbalances, symptomatic treatment, and adequate hydration.

Adverse Reactions

Within each frequency group, adverse reactions are listed in decreasing order of severity.

Summary table of frequency of adverse reactions.

The frequency of adverse reactions is classified as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated based on available data).

Reporting of suspected adverse reactions

Reporting of adverse reactions after the medicinal product has been registered is of great importance. It allows continuous monitoring of the benefit/risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life

3 years.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of the reach of children.

Packaging

30 ml in a polyethylene container with cap and dropper, together with a spray device, in a cardboard box.

Prescription status

Over-the-counter (without prescription).

Manufacturer

Joint Ukrainian-Spanish limited liability company "Sperko Ukraine".

Manufacturer's address and place of business

21027, 25, 600-richchya Street, Vinnytsia, Ukraine.

Marketing Authorization Holder

LLC "Representation BAUM PHARM GmbH".

Address of the Marketing Authorization Holder

66, Shyroka Street, Lviv, 79052, Ukraine.